The present invention relates to a consolidated system comprising various sectors of Digital Pathology which include whole slide scanning of biological specimens, image acquisition, image management and image interpretation/analysis using image analysis algorithms for detection of histological and immunohistochemical biomarkers, thereby aiding pathologists to draw improved and more accurate diagnosis of the pathological condition, and giving way to clinical development in immuno oncology with strong emphasis on specific immune regulatory checkpoints.
These hallmarks suggest that similar to the immune response they seek to measure, immune-biomarkers are diverse and inducible. Numerous factors are simultaneously engaged within the tumor microenvironment. Therefore, the presence or absence of any single immune-biomarker, including PD-L1, does not fully define immune status. Evaluating multiple immune-biomarkers in combination may provide a more accurate and comprehensive assessment. With respect to other FDA approved assays, further studies have shown that protein expressions on tumor infiltrating immune cells may predict response to immunotherapy better than on tumor cells alone. These tests are optimized to a threshold value based upon the number of cells demonstrating the protein expression on tumor cell (TC) and or immune cell (IC) membranes at or above the defined threshold intensity. However, evaluation of biomarker expression in lymphoid and other immune effector cells is a special challenge for pathologists. The above methods are implemented manually and experience to date has shown that interpretation by pathologists is more feasible and more reproducible for tumor cells than for infiltrating immune cells.
Immuno-oncology is based on the principle of provoking the patient's own immune system to boost an antitumor immune response in order to control or eradicate cancer cells. The recent advancements in immuno-oncology focusing on several specific immune regulatory checkpoints, one of which includes Programmed Death Ligand—1, has resuscitated the field of immune oncology. However, evaluation of multiple immune-biomarkers in combination with high resolution imaging offered by digital pathology with complex object recognition algorithms will provide a more comprehensive assessment and an aid for the pathologists to provide more accurate quantification of biomarkers. This will also help refine the understanding of converging immune and oncology pathways.
Digital Pathology offers captivating features which include a platform for image acquisition, image viewing, image interpretation, image analysis, image management and archival.
While all the above features/functions are available on separate platforms, there still lies a challenge in integrating/collaborating each of them on a single platform, supporting whole slide scanning, registration, segmentation and quantification of cancer cells based on biomarker content, thus opening the pathways to aid immuno oncology development.
US Patent No: 2012/0069049 A1 explains co-registration of multiple images, wherein two or more selected images may be automatically oriented for simultaneous viewing or automatically matched location on a reference image.
However there remains a need for an algorithm that addresses the following issues:
1. Fully automated analytics application integrated into whole slide scanner as the slide is being scanned without using a third party software as a holistic immuno-oncology tool
2. Fully automated analytics application integrated into whole slide scanner on a whole slide image or registered images stained with multiple biomarkers to facilitate 2D reconstruction and analytics
3. Fully automated analytics application integrated into whole slide scanner on serial sections yielding multiple whole slide images to facilitate 3D reconstruction and analytics